FDA biologics center director Peter Marks doubled down on the agency’s stance that its emergency use authorization guidance, hung up at the White House, simply lays out stricter criteria for potential COVID-19 vaccines that industry has been aware of for months, despite suggestions from the White House that the guidance is a political ploy.

Marks’ comments echo statements made by former FDA chiefs and public health experts who over the past few days have underscored that vaccine makers are aware of the agency’s so-called EUA-plus standards, and that they knew the guidance was coming.

“[There’s no reason] to get all excited, the companies know what we were expecting, [and that] this guidance was being done,”

Marks said Tuesday evening (Sept. 29) during the Friends of Cancer Research’s 24th Annual Cancer Leadership Virtual Reception.

President Donald Trump has asserted that the stricter EUA criteria appear to be a political move by the agency, and he said that the White House will review any standards created by FDA.

On Tuesday, though, Marks said the agency’s guidance was created to create transparency and boost public confidence in the safety and efficacy of a potential vaccine.

“Anything we can do to help engender trust in the process is critical. So this guide was an attempt to help the public see what we were requiring of COVID-19 vaccines,” Marks said. “The guidance was trying to explain what we expected and to reassure the public that we were going to have a transparent advisory committee meeting for each and every emergency use authorization that comes through.”

The expected guidance, if released, would publicly lay out the agency’s criteria for vaccine EUAs, which is stricter than the criteria for other products that have gone through the EUA process and actually leans closer to standards required for a biologics license application. The only difference is that the EUA applications will not include the same level of safety information as would be required for a BLA.

In addition, Marks said the guidance ensures that a public advisory committee meeting will be held for each vaccine that’s being considered for EUA and states that the public will have access materials submitted by companies and distributed by FDA.

Marks said that FDA must balance its goals of ensuring the safety of vaccines with efforts to get a vaccine to market quickly. FDA cannot set the bar for vaccine authorization so high that it prevents a candidate with an overall “very good” safety profile from entering the market as soon as possible, he said.

Marks also emphasized the importance of postmarket surveillance once a vaccine is authorized to treat COVID-19. FDA and the Centers for Disease Control and Prevention are already planning to conduct “heightened safety monitoring” for vaccines that come to the market under an EUA or a BLA.

Typically, vaccines that come to the market under a BLA have a follow-up of about 8,000 to 160,000 total years contributed by all the study participants, Marks said. But in the case of a potential COVID-19 vaccine EUA, the total amount of time would only be 25% to 50% of that amount. While the total amount of patient follow-up won’t be as large, Marks said the surveillance systems in place are “excellent” and will be used to the fullest extent.

https://insidehealthpolicy.com/daily-news/marks-covid-19-vaccine-eua-pl…